A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Basilar Migraine Clinical Trial

Official title:

An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158002
• Other study ID #: CAPSS 299
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: April 4, 2007
• Start date: February 2004
• Est. completion date: August 2006

Study information

• Verified date: April 2007
• Source: Monarch Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.

Description:

This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Must have either completed the Double-Blind Phase of CAPSS-271 or discontinued the Double-Blind Phase of CAPSS-271 due to lack of efficacy after a minimum of 2 weeks of maintenance treatment.

• Must continue to meet the specific inclusion criteria outlined in CAPSS-271.

• Female subjects must be premenarchal, surgically sterile (hysterectomy, tubal ligation or otherwise incapable of pregnancy); or practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) at study entry and throughout the study; or hormonal contraceptives for at least a 3-month period prior to the start of the study and throughout the study, or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. In addition, female subjects of childbearing potential must have a negative urine pregnancy test at Open-Label Visit 1 (Day 1).

• Must be able to read and comprehend written instructions and be willing to complete all headache records and questionnaires as required by the protocol.

• After full explanation of the study, subjects, or their parent/legally authorized representative(s), must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.

Exclusion Criteria:

• Subjects who have developed a more painful condition than their headache pain.

• Subjects taking any of the prohibited concomitant medications (See Concomitant Medications section).

• Subjects who are pregnant.

• Subjects with liver function tests ³ 2 times the upper limit of the normal range.

• In the investigator’s opinion, subjects with poor compliance during the CAPSS-271 study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Basilar Migraine
• Migraine Disorders

Intervention

Drug:
• Topiramate

Locations

Country	Name	City	State
United States	Monarch Medical Research - Child and Adolescent Neurology	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Monarch Medical Research	Ortho-McNeil Neurologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of average monthly migraine days
Primary	Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
Primary	Reduction in migraine pain severity and duration
Primary	Migraine episode and headache episode frequency
Primary	Total headache days
Primary	Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
Secondary	Cumulative frequency of migraine days and migraine episodes
Secondary	Use of acute/abortive medications
Secondary	Migraine episode and headache episode frequency
Secondary	Total headache days
Secondary	Migraine-associated symptoms